United States - English - NLM (National Library of Medicine)

otsuka america pharmaceutical, inc. - aripiprazole (unii: 82vfr53i78) (aripiprazole - unii:82vfr53i78) - aripiprazole 2 mg - abilify (aripiprazole) oral tablets, orally-disintegrating tablets, and oral solution are indicated for the treatment of: - schizophrenia - acute treatment of manic and mixed episodes associated with bipolar i disorder - adjunctive treatment of major depressive disorder - irritability associated with autistic disorder - treatment of tourette's disorder abilify injection is indicated for the treatment of: - agitation associated with schizophrenia or bipolar mania abilify is contraindicated in patients with a history of a hypersensitivity reaction to aripiprazole. reactions have ranged from pruritus/urticaria to anaphylaxis [see adverse reactions (6.2)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including abilify, during pregnancy. healthcare providers are encouraged to register patients by contacting the national pregnancy registry for atypical antipsychotics at 1-866-961-2388 or visit http://womensmentalhea

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

otsuka pharmaceuticals (u.k. - tolvaptan - tablet - 15mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

otsuka pharmaceuticals (u.k. - aripiprazole - powder and solvent for suspension for injection - 400mg

European Union - English - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - tolvaptan - polycystic kidney, autosomal dominant - diuretics, - jinarc is indicated to slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (adpkd) in adults with ckd stage 1 to 3 at initiation of treatment with evidence of rapidly progressing disease.

European Union - English - EMA (European Medicines Agency)

otsuka pharmaceutical netherlands b.v. - tolvaptan - inappropriate adh syndrome - diuretics, - treatment of adult patients with hyponatraemia secondary to syndrome of inappropriate antidiuretic-hormone secretion (siadh).,

United States - English - NLM (National Library of Medicine)

otsuka america pharmaceutical, inc. - busulfan (unii: g1ln9045dk) (busulfan - unii:g1ln9045dk) - busulfan 6 mg in 1 ml - busulfex is indicated for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia. busulfex is contraindicated in patients with a history of hypersensitivity to any of its components. risk summary busulfex can cause fetal harm when administered to a pregnant woman based on animal data. busulfan was teratogenic in mice, rats, and rabbits following administration during organogenesis. the solvent, dma, may also cause fetal harm when administered to a pregnant woman. in rats, dma doses of approximately 40% of the daily dose of dma in the busulfex dose on a mg/m2 basis given during organogenesis caused significant developmental anomalies (see data ). there are no available human data informing the drug-associated risk. advise pregnant women of the potential risk to a fetus. the background risk of major birth defects and miscarriage for the indicated populations are unknown. however, the background risk

United States - English - NLM (National Library of Medicine)

otsuka america pharmaceutical, inc. - brexpiprazole (unii: 2j3ybm1k8c) (brexpiprazole - unii:2j3ybm1k8c) - brexpiprazole 0.25 mg - rexulti is indicated for: - adjunctive treatment of major depressive disorder (mdd) in adults - treatment of schizophrenia in adults and pediatric patients ages 13 years and older - treatment of agitation associated with dementia due to alzheimer's disease limitations of use: rexulti is not indicated as an as needed ("prn") treatment for agitation associated with dementia due to alzheimer's disease [see clinical studies (14.3)] . rexulti is contraindicated in patients with a known hypersensitivity to brexpiprazole or any of its components. reactions have included rash, facial swelling, urticaria, and anaphylaxis. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to rexulti during pregnancy. for more information contact the national pregnancy registry for atypical antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/ . risk summary adequate and well-controlled studies have not

Australia - English - Department of Health (Therapeutic Goods Administration)

otsuka australia pharmaceutical pty ltd - busulfan, quantity: 60 mg - injection - excipient ingredients: dimethylacetamide; macrogol 400 - busulfex is indicated for use in combination with cyclophosphamide, melphalan or fludarabine in conditioning prior to haematopoietic stem cell transplantation.

Australia - English - Department of Health (Therapeutic Goods Administration)

otsuka australia pharmaceutical pty ltd - cilostazol -

Australia - English - Department of Health (Therapeutic Goods Administration)

otsuka australia pharmaceutical pty ltd - cilostazol -